SmithKline Corp. v. Food and Drug Administration

In 1971, Smith, Kline & French Laboratories (SKF) sought New Drug Approval (NDA) from the Food and Drug Administration (FDA) for its obesity drug, Dexamyl. Dexamyl was a combination drug that contained an appetite suppressant, Dexedrine, and amobarbital, a barbiturate to counteract any anxiety caused by the Dexedrine. In 1973, SKF submitted the results of five of its double-blind, multi-investigator clinical trials testing the efficacy of Dexamyl. Within weeks, the FDA informed SKF that its record regarding Dexamyl was closed and that no further data would be accepted. In 1976, the FDA published an order denying a hearing and refusing to approve the pending NDA for Dexamyl, because it found that none of the evidence submitted by SKF met the regulatory standards for adequate and well-controlled studies. FDA regulations, and the Supreme Court, permit such summary judgment procedures when an applicant has failed to submit substantial evidence of a drug’s efficacy sufficient to meet FDA regulatory standards. Prior to the FDA order, SKF had not received any criticism from the FDA about SKF’s clinical trials. SKF obtained expert review and affidavits averring the adequacy of its studies and filed suit for judicial review of the FDA’s summary judgment and order and sought remand to the FDA for an evidentiary hearing. The FDA noted several objections to SKF’s clinical trials, including: (1) use of anxious subjects, (2) consistent observation methods, (3) whether the washout period for amphetamines equalizes anxiety levels of subjects, (4) data aggregation issues regarding pooling, (5) use of an active control, and (6) observer and data analyst bias. SKF alleged that the FDA’s criticisms of its clinical trials were based on scientifically fallacious and imprecise regulations.